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NCT01222247 · ClinicalTrials.gov registry record · Phase 3
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,831
- Enrollment target
NCT01222247: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.
NCT01222247 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 2,831 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222247, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,831 participants
- Enrollment target
Study Summary
This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
Primary Outcome
Need for respiratory support: Continuous positive airway pressure (CPAP) or humidified high-flow nasal cannula (HHFNC) for greater than or equal to 2 hours or more in the first 72 hours, or fraction of inspired oxygen (FiO2) greater than or equal to 0.30 for 4 hours or more in the first 72 hours, or mechanical ventilation in the first 72 hours, or Extracorporeal membrane oxygenation (ECMO) Stillbirth, or neonatal death less than 72 hours of age
Interventions
- DRUG Placebo
- DRUG Betamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,831 participants |
| Start Date | 2010-10 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 3 |
What the finished NCT01222247 record still lists
NCT01222247 is an interventional study that assigns participants to a tested intervention. Its 2,831 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (267% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01222247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01222247 about?
NCT01222247 is a clinical study titled "Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial". This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been s...
What is the current status of trial NCT01222247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,831 participants. The study started on 2010-10. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT01222247?
The interventions under investigation include: Placebo (DRUG), Betamethasone (DRUG).
Who is sponsoring clinical trial NCT01222247?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01222247's enrollment target sits among peer trials
2,831 81st of 2000 higher than 1,920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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